Apparatus and method for microcurrent stimulation therapy

ABSTRACT

Apparatus and method for treatment of a human condition and more particularly for applying bio-electric microcurrent stimulation therapy to the human body, via an apparatus which connects to a micro-stimulation current generating device, and application of microcurrent stimulation therapy, that includes a headset device encircling the head, and connected to electrode strips (such as a one-use disposable chip-electrode array having a unique serial number or crypto code and other functionality that is used by the system to look up and deliver customized therapy to a particular patient having their own particular symptoms and medical history), which deliver the stimulation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority benefit, including under 35 U.S.C. §119(e), of U.S. Provisional Patent Application No. 62/783,116 filed Dec.20, 2018 by Marshall T. Masko, et al., titled “Apparatus and Method forMicrocurrent Stimulation Therapy,” which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates to treatment of a human condition and moreparticularly to an apparatus and a method for applying bio-electricmicrocurrent stimulation therapy to the human body, via an apparatuswhich connects to a micro-stimulation current generating device, andapplication of microcurrent stimulation therapy, that includes a headsetdevice encircling the head, and connected to electrode strips (such as aone-use disposable chip-electrode array having a unique serial number orcrypto code and other functionality that is used by the system to lookup and deliver customized therapy to a particular patient having theirown particular symptoms and medical history), which deliver thestimulation. In some embodiments, the apparatus also either contains astimulation controller device or is connected to a separate controldevice, via either wired or wireless communications. Some embodimentsinclude applying bio-electric microcurrent stimulation therapy formacular degeneration, retinitis pigmentosa, glaucoma, optic neuritis,Bell's Palsy and other eye diseases to key points around the eye, aswell as other diseases requiring localized and precision stimulation onother body parts.

BACKGROUND OF THE INVENTION

Chronic pain is a problem for millions of individuals throughout theworld. One method of treating such pain is to provide microcurrentstimulation around or near the areas where the pain is occurring.Microcurrent, which typically is defined as current below 1 milliamp,can provide rapid and long-lasting pain relief for a wide variety ofpain syndromes. Generally, microcurrent stimulation therapy typicallyincludes applying a current in the range of about 20 to about 300microamps to the affected area. The current blocks neuronal transmissionof pain signals and stimulates the release of endorphins to help relievethe pain in chronic and acute pain patients. Within certain levels ofthis range, the microcurrent mimics the body's own electrical currentlevel and is what we term “bio-electric current.”

In addition to chronic pain relief, microcurrent therapy is being usedto treat a number of visual diseases, including macular degeneration,retinitis pigmentosa, and glaucoma, among other eye diseases. It isbelieved through secondary literature that this microcurrent treatmentstimulates blood flow, increases ATP (adenosine triphosphate) at thecellular level, and enhances cellular permeability. Further, it isbelieved such stimulation can re-establish functional neural pathwaysfor muscle and brain, as well as for blood vessel and brain.

1. Primary Disease for Treatment (AMD)

Age-related Macular degeneration (AMD) is a very common eye disease,affecting more people than glaucoma. Macular degeneration is the mostfrequent cause of blindness for patients aged 60 and above in the UnitedStates, and is estimated to affect over 10 million Americans. (Source:National Health Institute). Macular degeneration results in thedeterioration of various retinal tissues in the region of the macula,the central, most sensitive light-sensing area of the retina responsiblefor detailed central vision. Impaired blood circulation in the centralretina, with partial to full corresponding vision loss, is a typicalconsequence of macular degeneration.

Costs of Healthcare and Eye Care

The U.S. spends $2.7 trillion in healthcare each year, of which eye carerepresents roughly three percent or $60-$70 billion of the total.According to Eurostat, the European Union (EU) spends 45.7% of thatamount or about $1.23 trillion. Expenditures for eye care are growing atsix percent annually. According to the National Institutes of Health(NIH), it is expected to continue to grow at least six percent over thenext several decades, driven by the aging population.

Macular degeneration causes about $184 billion in lost productivity eachyear and approximately $51 billion is spent treating maculardegeneration each year in the United States. 90% of macular degenerationcases are the “Dry” or non-bleeding form, termed “Atrophic AMD,” andabout 10% of cases are the “Wet” or bleeding form, termed “ExudativeAMD.”

Disease Prevalence

Because there is currently no approved treatment for dry AMD, littleresearch has been done on the market potential. There is, however,significant data on the large numbers of people affected by AMD and isestimated to cause about 8.7% of blindness and low vision globally.According to a report from the World Health Organization, “AMD is theprimary cause of blindness in the developed countries and the thirdleading cause worldwide.” The prevalence of AMD in Europe is estimatedto be: 16.3 million people (excluding southeastern and Eastern Europe),and in the United States 10.2 million people. (Source:www.wrongdiagnosis.com).

Further, this increases to a combined total of 41 million when adding inCanada, Australia/New Zealand, Russia, and Japan. Ninety percent (90%)of these cases are dry AMD for which there is no currently approvedtreatment to restore vision.

Approximately 25% of the population (in the target markets, aged 65 to75 years old) has AMD, and this increases to 35% for ages 75 and older.Within the next 10 to 20 years, as baby boomers reach their mid-sixtiesand older, the prevalence of the disease is projected to dramaticallyincrease. In a study funded by the U.S. Centers for Disease Control andPrevention, researchers reported that as many as 9.1 million people inthe U.S. had AMD in 2010 and 17.8 million would have it by 2020.

Causes of AMD

Normal retinal cell function is a photochemical reaction convertinglight energy to an electrical impulse which travels to the brain andvision occurs. With AMD and other visual system diseases, diseased,inflamed retinal cells eventually lose cell function. Adenosinetriphosphate (ATP) levels drop, protein synthesis drops, the electricalresistance goes up, and cell membrane electrical potential goes down.Basically, the cells would appear to go dormant for a time before theydie.

It is believed that, when electrical stimulation is provided to thecells before they die, blood vessel permeability is increased, normalcellular electrical potential is achieved, the ATP levels increase,protein synthesis will occur again, and normal cell metabolism isrestored thereby improving or restoring vision loss. In addition, invitro studies have demonstrated that electrical stimulation appears tohave a healing effect on the small blood vessels in the retina,promoting a more efficient delivery of nutrients to the retinal cellsand a more efficient elimination of metabolic by-products.

The retinal pigment epithelium (RPE) is the support-cell complex for thephotosensitive rod and cone cells which make up the light-sensingretina. The RPE is the first to be affected by circulation impairment.Once affected by poor circulation, the RPE cannot efficiently assist therods and cones in removing the metabolic and photochemical responseby-products, which are common during cellular function.Yellowish-colored sub-retinal deposits called “drusen” form whenextracellular by-products are not carried away by blood circulatingthrough the eye. As a result, the photoreceptor cells in the maculaenter a dormant, toxic state and do not respond to light. If normalretinal cellular metabolism is not restored, the cells die and visualacuity is permanently lost. Thus, it is believed that microcurrentstimulation will help rejuvenate the cells in the retina to slow or stopdegeneration of the eye due to AMD.

5. Potential Treatment/Solution

Clinical studies have demonstrated that with the proper bio-electricmicrocurrent stimulation waveform and therapy procedure, AMD may beslowed or stopped in a large number of people suffering from thedisease. But, the efficacy of these therapies can be affected by themanual techniques medical professionals use to administer said therapy.Where patients have significant skin impedance, or there is a poorconductivity, uptake of the stimulation level is limited and will limitthe treatment efficacy. This invention, consisting of a headsetappliance of electrodes in a circular, or semi-circular fashion aroundthe eye addresses that problem by communicating, via sensors, with anapparatus that generates bio-electric microcurrent stimulation.

U.S. Pat. No. 10,391,312, issued Aug. 27, 2019 to Blair P. Mowery et al.and titled “APPARATUS AND METHOD FOR OCULAR MICROCURRENT STIMULATIONTHERAPY,” is a U.S national phase of

PCT Application Serial Number PCT/US16/51550 filed on Sep. 13, 2016 withthe title “APPARATUS AND METHOD FOR OCULAR MICROCURRENT STIMULATIONTHERAPY,” which claims priority to

U.S. Provisional Patent Application No. 62/283,870 filed on Sep. 15,2015 by Blair Phillip Mowery et al., titled “Appliance formicrostimulation therapy using a disposable material afixed to the upperand lower eye lid & other body parts,”

U.S. Provisional Patent Application No. 62/283,871 filed on Sep. 15,2015 by Marshall T. Masko et al., titled “Apparatus for a method ofapplication of microcurrent stimulation therapy, consisting of a goggledevice affixed to and encircling the upper and/or lower eyelids, as wellas other body parts,” and

U.S. Provisional Patent Application No. 62/365,838, filed Jul. 22, 2016by Tapp et al., titled “Appliance for micro-current stimulation,” eachof which is incorporated herein by reference in its entirety.

U.S. Pat. No. 10,391,312 describes devices and methods to delivermicrocurrent stimulation therapy to the human body, when connected to amicro-stimulation current-generating apparatus. The method of applyingmicrocurrent stimulation therapy to key points around the eye fortreatment of problems such as macular degeneration, retinitispigmentosa, glaucoma, optic neuritis and other eye-related ornerve-related conditions, as well as other diseases, such as Bell'sPalsy, requiring localized stimulation to the eyes and/or on other bodyparts.

U.S. Pat. No. 6,035,236 issued to Jarding, et al. on Mar. 7, 2000 withthe title “Methods and apparatus for electrical microcurrent stimulationtherapy” and is incorporated herein by reference in its entirety. U.S.Pat. No. 6,035,236 describes an apparatus for supplying an electricalsignal to a body part in order to provide microcurrent stimulationtherapy to the body part. The apparatus preferably includes a firstsweep wave or sweep frequency signal generator configured to generate afirst sweep wave signal, a buffer amplifier circuit configured toreceive the first sweep wave signal from the first sweep signalgenerator and amplify and buffer the sweep wave signal creating abuffered sweep wave signal. In addition, the apparatus preferablyincludes a current limiting circuit configured to receive the bufferedsweep wave signal from the buffer amplifier circuit and limit the amountof current supplied to the body part. Finally, the apparatus preferablycomprises a probe for applying the sweep wave signal to the body part.The apparatus may further comprise a second signal generator forgenerating a second signal which may comprise either a sweep wave signalor a non-sweep wave signal. The apparatus also will include a signalcombining circuit configured to receive the first and second signalsfrom the first and second signal generators and combine the first andsecond signals into a composite sweep wave signal.

U.S. Pat. No. 6,275,735 issued to Jarding et al. on Aug. 14, 2001 withthe title “Methods and apparatus for electrical microcurrent stimulationtherapy” and is incorporated herein by reference in its entirety. U.S.Pat. No. 6, 275,735 describes a method and apparatus for providingmicrocurrent stimulation therapy to a body part. In one embodiment, amethod allows digital control of the modulation frequency of themicrocurrent signal. The method includes receiving a first digital dataword which is used to produce a first frequency related to the firstdigital data word, whereupon, a first microcurrent signal at the firstfrequency is applied to the body part. A second digital data word isreceived and used to produce a second frequency related to the seconddigital data word. A second microcurrent signal at the second frequencyis applied to the body part. In another embodiment, a method allowsdirect digital synthesis of the microcurrent stimulation signal. A firstdigital data word is used to produce a first analog voltage which isapplied to the body part. A second digital data word is used to producea second analog voltage which is also applied to the body part, wherethe first analog voltage is different from the second analog voltage. Inyet another embodiment, an apparatus for providing microcurrentstimulation therapy includes a digital-to-analog converter, a controllerand a plurality of data words. The controller is coupled to thedigital-to-analog converter and supplies the digital-to-analog converterwith digital data words in order to generate an electrical signal forthe microcurrent stimulation therapy.

United States Patent Application Publication 2014/0081369 by Sosa,Victor Manuel Valencia et al. published on Mar. 20, 2014 with the title“HEADACHE-TREATMENT DEVICE WITH GEL DISPENSING KIT AND METHOD” and isincorporated herein by reference in its entirety. Patent ApplicationPublication 2014/0081369 describes an electrical-stimulation device withgel-dispensing kit, and a method of making and using the parts of thekit. A convenient and easy-to-use system to provide an electricallyconductive path from a transcutaneous electrical nerve stimulation(TENS) device to the skin surface of a patient to supply transcutaneousstimulation, even through hair. The invention provides improvedprevention and treatment for headache, depression, alertness, attentiondeficit hyperactivity disorder (ADHD), epilepsy, anxiety, post-traumaticstress disorder (PTSD), and behavioral and/or other disorders. Someembodiments provide a headache-treatment system that includes anelectrode base shaped to conform to a back of a human head; a TENShaving projecting spring electrodes each connected to the electrodebase; means for holding an electrically conductive gel in a plurality ofsealed pockets; and means for unsealing the means for holding the geland applying the gel substantially simultaneously to the projectingspring electrodes.

United States Patent Application Publication 2017/0300098 by Sen et al.published on Oct. 19, 2017 with the title “SUPPLYING POWER TO A COMPUTERACCESSORY FROM A CAPTURED WIFI SIGNAL” and is incorporated herein byreference in its entirety. Patent Application Publication 2017/0300098describes examples of capturing a Wi-Fi signal from a computing devicecorresponding to a computing accessory and harvesting energy from thecaptured Wi-Fi signal. The examples power the computing accessory basedon the harvested energy.

United States Patent Application Publication 2008/0028214 by Tafoya etal. published on Jan. 31, 2008 with the title “Secure flash media formedical records” and is incorporated herein by reference in itsentirety. Patent Application Publication 2008/0028214 describes a securemobile device for storing data in a secure manner. The secure mobiledevice has a microarchitecture connected via an interface to flashmemory on the device. The microarchitecture is able to authenticate theaccess of information stored on the secure mobile device using a privatekey. Upon authentication of the access of information, a record owner ofthe device may provide the stored information to third party trustedentities using an associated public key. The secure mobile device allowsfor secure transaction of confidential data on a variety of systems at anumber of locations.

U.S. Pat. No. 6,385,727 issued to Cassagnol et al. on May 7, 2002 withthe title “Apparatus for providing a secure processing” and isincorporated herein by reference in its entirety. U.S. Pat. No.6,385,727 describes a secure processing environment. In one embodiment,the apparatus includes a read/write memory for storing encryptedinformation. It also includes a processor, a cipherer and anauthenticator. The cipherer is in communication with the read/writememory for receiving encrypted information therefrom and is configuredto decrypt the encrypted information into decrypted information to bereturned to the memory for subsequent use by the processor. Theauthenticator authenticates the decrypted information prior to use bythe processor and re-authenticates the information prior tore-encryption by the cipherer

There is a long-felt need for an improved method and apparatus formicro-stimulation electrical therapy.

SUMMARY OF THE INVENTION

The bio-electric micro-stimulation apparatus is comprised of a headset,similar to a crown, which connects to electrodes for each eye to providestimulation, when in contact with the skin around the outer closed eye,encircling and/or overlapping the outer orbital cavity. The electrodes'contact points deliver the bio-electric microcurrent therapy, when theheadset is connected to a bio-electric micro-stimulation device (i.e., a“controller”) that generates and conveys such current.

In some embodiments, the treatment electrodes contain a micro-chip(i.e., a “chip”) to authenticate itself and connect with the headset tocontrol therapy, payment, and usage. In addition, there is a groundingelectrode component as well, consisting of one or two groundingelectrodes. The headset connects to the bio-electric micro-stimulationdevice (“controller”) in one of three ways: (i) the controller is builtinto the headset; (ii) the controller is connected via wires to theheadset and/or to the electrodes; or (iii) the controller connects tothe headset via WIFI or Bluetooth®. The Wikipedia entry for “Wi-Fi”indicates: “Wi-Fi is technology for radio wireless local area networkingof devices based on the IEEE 802.11 standards.” The Wikipedia entry for“Bluetooth” indicates: “Bluetooth is a wireless technology standard forexchanging data over short distances (using short-wavelength UHF radiowaves in the ISM band from 2.400 to 2.485 GHz) from fixed and mobiledevices, and building personal area networks (PANs).” The headset may beadjustable to fit various sized heads, or it may have an open-ended backwhich does not completely encircle the head (similar to eyeglasstemples), so as to fit any sized head.

In some embodiments, the headset also connects via WIFI or Bluetooth® toserver or computer, which recognizes the individual headset viaalgorithmic codes built into the headset's control unit. Once the serveror computer is connected to the headset and recognizes the headset'sunique algorithmic code, it can enable the headset, when initiated by aclinician or physician to conduct a treatment session and it cansimultaneously bill or charge the provider for payment of such treatmentsession. The headset is rechargeable and is recharged via a basestation.

This description of the invention uses the term “bio-electricmicrocurrent” because the microcurrent level selected for the appliedtherapy mirrors the body's own biological electrical current. Hence theterm: “bio-electric current.”

In some embodiments, this headset device is not a disposable unit.Further, since it does not directly touch the treated eye area, (incontrast, the electrodes, which are disposable, do touch the treatedarea), there is no need for repeated sterilization or sanitization toavoid cross-patient eye contamination. The headset device will bemaintained at a sanitary standard.

In some embodiments, the electrodes, which connect to the headset, havea conductive gel (or the like) applied on the inner perimeter at theelectrode points for proper conductivity for stimulation therapy, whichgenerates the prescribed bio-electric microcurrent at an appropriateamplitude, duty cycle, and/or repetition rate or frequency to theappropriate area of the eye, in a timed and dosed sequence to themultiple electrode points on the electrodes affixed near or to the eyelids. In some embodiments, the electrode points also connect to a sensor(such as an electrical preamplifier and/or analog-to-digital converters,or sensors embedded in the headset or in the outside stimulation device,which will provide feedback to the device to measure for any impedance,and contain the ability to automatically adjust the current level tomaintain the initially selected prescribed treatment bio-electriccurrent level.

Microcurrent stimulation therapy has begun to be used to treatage-related muscular degeneration (AMD) and other visual systemdiseases; however, the methods and apparatus used in the prior art donot maximize the therapeutic effect and do not provide a way to monitorthe therapeutic delivery and encourage patient compliance with theprescribed treatment regimen. Current devices may not deliver properlyconcentrated stimulation signals at the point where it is appropriatelyneeded. In addition, stimulation levels can encounter impedance, whichblocks or reduces the stimulation level chosen, thereby failing todeliver the appropriate level of stimulation required for propertreatment.

This new invention contains a method to carry and apply an electricalsignal, termed “bio-electric microcurrent,” which is a form ofelectrical stimulation, or “e-stim,” to a specific body part, in thiscase the eye, or other selected body parts for treatable diseases, topromote or enable healing of the selected and treated tissue areas.Bio-electric microcurrent is that microcurrent ramie (100 IA to 350 LA)pulsed into the body, which mimics the body's own electric current. Saidapparatus can deliver the appropriate stimulation to specificallytargeted selected areas, as well as maintain the appropriate pressurerequired to eliminate or minimize patient impedance, while alsocontinuously monitoring the stimulation level delivered to the patient,via a proprietary sensor to ensure it stays consistent with the levelselected by the clinician, regardless of impedance or other issues. Theinvention, which is placed on the upper and lower eye lids, via thesensor, can automatically adjust such stimulation to the initialprescribed dosage when impedance is detected. The present inventionprovides this and other solutions to ensure optimum therapy isdelivered, during the administration of treatments for maculardegeneration and other eye disease problems.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention may be derived byreferring to the detailed description and claims when considered inconnection with the figures, wherein like reference numbers refer tosimilar items throughout the figures.

FIG. 1A is a block diagram of a system 101 for delivering stimulationsignals to at least some of a plurality 116 of electrodes connected tothe skin of a patient and for optionally sensing signals from at leastsome of the plurality 116 of electrodes, according to some embodimentsof the present invention.

FIG. 1B is a block diagram of a system 102 for delivering stimulationsignals to at least some of a plurality 116 of electrodes connected tothe skin of a patient and for optionally sensing signals from at leastsome of the plurality 116 of electrodes, according to some embodimentsof the present invention.

FIG. 1C is a diagram of a system 103, according to some embodiments ofthe present invention.

FIG. 1D is a cross-section diagram of and electrode-and-gel system 104,according to some embodiments of the present invention.

FIG. 1E is a cross-section diagram of an electrode-and-gel system 105,according to some embodiments of the present invention.

FIG. 2 is a diagram of a goggle-type device 201, according to someembodiments of the present invention.

FIG. 3 is a diagram of a goggle-type device 301, according to someembodiments of the present invention.

FIG. 4A is a diagram of a goggle-type device 401, according to someembodiments of the present invention.

FIG. 4B is a diagram of a system 402, according to some embodiments ofthe present invention.

FIG. 5 is a diagram of a goggle-type device 501, according to someembodiments of the present invention.

FIG. 6 is a diagram of goggle-type device 601, according to someembodiments of the present invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

Although the following detailed description contains many specifics forthe purpose of illustration, a person of ordinary skill in the art willappreciate that many variations and alterations to the following detailsare within the scope of the invention. Specific examples are used toillustrate particular embodiments; however, the invention described inthe claims is not intended to be limited to only these examples, butrather includes the full scope of the attached claims. Accordingly, thefollowing preferred embodiments of the invention are set forth withoutany loss of generality to, and without imposing limitations upon theclaimed invention. Further, in the following detailed description of thepreferred embodiments, reference is made to the accompanying drawingsthat form a part hereof, and in which are shown by way of illustrationspecific embodiments in which the invention may be practiced. It isunderstood that other embodiments may be utilized and structural changesmay be made without departing from the scope of the present invention.

It is specifically contemplated that the present invention includesembodiments having combinations and subcombinations of the variousembodiments and features that are individually described herein (i.e.,rather than listing every combinatorial of the elements, thisspecification includes descriptions of representative embodiments andcontemplates embodiments that include some of the features from oneembodiment combined with some of the features of another embodiment,including embodiments that include some of the features from oneembodiment combined with some of the features of embodiments describedin the patents and application publications incorporated by reference inthe present application). Further, some embodiments include fewer thanall the components described as part of any one of the embodimentsdescribed herein.

The leading digit(s) of reference numbers appearing in the Figuresgenerally corresponds to the Figure number in which that component isfirst introduced, such that the same reference number is used throughoutto refer to an identical component which appears in multiple Figures.Signals and connections may be referred to by the same reference numberor label, and the actual meaning will be clear from its use in thecontext of the description.

Certain marks referenced herein may be common-law or registeredtrademarks of third parties affiliated or unaffiliated with theapplicant or the assignee. Use of these marks is for providing anenabling disclosure by way of example and shall not be construed tolimit the scope of the claimed subject matter to material associatedwith such marks.

Overview of the New Technology

Embodiments of the present invention replace the need for manualapplication of the therapy currently used by a clinical professional.The appliance comprises a headset, connecting to a gel-strip orgel-strips containing electrodes and sensors for applying thebio-electric microcurrent therapy to the body part, in this case theeye. The headset's circular inner frame is positioned on the patient'shead for both comfort and ease of treatment application. The headset iswired to either a self-contained controller or wired to connect to aseparate bio-electric microcurrent stimulation device that generates theprescribed bio-electric microcurrent in sequence to the multipleelectrode points on the material strips placed over to totality of theeye, or above and under the eye. The control device to which the headsetinvention is connected also contains a software system that isprogrammed to not only sequence the therapy to the various points on thematerial but also to detect impendence and adjust the level ofbio-electric microcurrent to achieve optimum therapy.

In some embodiments, the present invention could be useful to include ina therapy for treating cancer or other maladies, for example byactivating (or suppressing) chemicals of a chemotherapy or antibodies ofan immunotherapy directed to a particular volume of tissue such as atumor.

In some embodiments, the present invention includes an apparatus thatreplaces the need for long manual applications of themicrocurrent/electrostimulation therapy currently used or beingenvisioned as used by a clinical professional. And, it also enables theclinician or physician to deliver stimulation to a particular designatedpoint on the body, as opposed to a broader coverage or blanketed area ofthe body. Current technologies have two major drawbacks. First,stimulation delivered with a probe or pointer, is applied manually andtakes a large amount of clinician time to administer it and properlydeliver it. Secondly, when gel pads are used in any kind ofelectrostimulation or microcurrent therapy, the gel pads cover anddeliver stimulation affecting a broad part of the human body, usuallywell in excess of 20 millimeters. This shortcoming of conventionalsystems prevents the delivery of stimulation to a “pinpointed” area of2-15 millimeters, which present invention does allow for, and can incertain treatment therapies, be more efficacious with a greaterstimulation level delivered on a smaller surface area that penetratesmore deeply and improves treatment performance.

FIG. 1A is a block diagram of a system 101 for delivering stimulationsignals to at least some of a plurality 116 of electrodes connected tothe skin of a patient and for optionally sensing signals from at leastsome of the plurality 116 of electrodes, according to some embodimentsof the present invention. In some embodiments, system 101 includes aone-use disposable chip-electrode array 110 (which may include one ormore integrated-circuit chips 111 and/or other circuitry along with anarray of electrodes 116 on a flexible and/or elastic substrate 119 suchas described in U.S. Pat. No. 10,391,312 issued on Aug. 27, 2019 toBlair P. Mowery et al., titled “APPARATUS AND METHOD FOR OCULARMICROCURRENT STIMULATION THERAPY,” which is incorporated herein byreference), a local microprocessor system 120, and a central server 130,wherein chip-electrode array 110 is communicatively coupled to localmicroprocessor system 120, and local microprocessor system 120 iscommunicatively coupled to central server 130. In some embodiments,chip-electrode array 110 communicates with local microprocessor system120 via a wired connection, and/or by a wireless connection such asBluetooth®, Wi-Fi, infrared light, or the like. In some embodiments,chip-electrode array 110 is powered by a local power source 113 such asa battery, while in other embodiments, power 114 is supplied by a wiredconnection or, for example, from power captured from the Wi-Fi signalsuch as described in United States Patent Application Publication20170300098 by Sen et al. which published on Oct. 19, 2017 with thetitle “SUPPLYING POWER TO A COMPUTER ACCESSORY FROM A CAPTURED WIFISIGNAL,” and which is incorporated herein by reference. In someembodiments, chip-electrode array 110 includes circuitry such as amicroprocessor and signal processor 111 (in some embodiments,microprocessor and signal processor 111 is implemented as a single chipthat is integral; in some other embodiments, the circuitry formicroprocessor and signal processor 111 is implemented by a plurality ofintegrated circuit chips).

In some embodiments, microprocessor and signal processor 111 has anembedded unique serial number (USN) information 118 that uniquelyidentifies each one of the chip-electrode arrays 110 of a plurality ofidentical or similar devices in order that quality control is maintained(e.g., by tracking the manufacturing date, batch, version, and the likeby the serial number (e.g., in some embodiments, in a device database133) to help ensure that the device is fresh (not expired) and hasup-to-date functionality and features suitable for each particularpatient).

In some embodiments, embedded serial number information 118 furtherincludes public-key encryption information that is used by server 130 toencrypt data being sent back to chip-electrode array 110, whereprivate-key information needed to decrypt the returned encrypted data124 from server 130 remains hidden inside microprocessor and signalprocessor 111 (e.g., in some embodiments, the decryptor is part of dataand software in decryptor/pulse-enable-and-control module 112). In someembodiments, the present invention uses public-key encryptionprivate-key decryption methods and systems such as described in UnitedStates Patent Application Publication 2008/0028214 by Tafoya et al. orU.S. Pat. No. 6,385,727 to Cassagnol et al. Such systems allow thedestination system (in this case, the microprocessor and signalprocessor 111) send out a public key that any source (in this case,server 130) can use to encrypt data that requires the correspondingprivate key (which is not publicly available) to correctly descript thedate returned from the source.

In some embodiments, the returned data 128 contains medically relevantstimulation-control parameters that are customized (potentiallydifferently) for each particular patient or population of patientshaving a given set of diagnoses and physiological data. In someembodiments, results of each therapy are collected in database 134 andare collectively analyzed to obtain improved future therapy sessions.

By using public-key/private-key communications between themicroprocessor and signal processor 111 and server 130, the returneddata 124 can be checked for validity or modifications after decryptionusing the private key data in microprocessor and signal processor chip111, and the risk of third parties accessing the information, includingpatient's data, is reduced. In some embodiments, local microprocessorsystem 120 also receives a unique patient identifier (UPID) 121associated with the particular patient who is to receive therapy. Insome embodiments, the UPID is associated with the patient but in a senserelatively anonymous until used by the server 130 to associate that UPIDto the patient PII and medical history 122 in server 130. In someembodiments, local microprocessor system 120 appends (or otherwisecombines) the USN 118 and UPID 121, and in some embodiments, encryptsthe result via encryptor-encapsulator-transmission circuit 125 and thentransmits this information to server 130 (e.g., via a cell phoneconnection and/or the internet or the like).

In some embodiments, a separate process 122 is used to input morecomplete patient personal identifying information (PII) and thepatient's medical history that, in some embodiments, is encrypted andstored in patient database (PAT DB) 132. In some embodiments, server 130includes a decryptor/encryptor function 131 that decrypts data fromtransmitted data 129 to locate and retrieve data associated with theparticular patient from patient database 132. In some embodiments, thepatient information itself as stored on PAT DB 132 is encrypted, and sowhen retrieved, the data needs to be decrypted (at least in part) bydecryptor 136.

In various embodiments of the present invention, the functions shown inFIG. 1A and FIG. 1B are implemented as a combination of hardwarecircuitry and software, wherein the some of the various parts of thecombination of hardware circuitry and software are implemented in theone-use disposable chip-electrode array 110, in a stand-alone localmicroprocessor 120 and/or in one or more mobile communications device(s)such as a cell phone, laptop, iPad® or the like. In some embodiments,some or all of local microprocessor system 120 and/or its functiondescribed above is located in a head-worn (goggle-type) apparatus wornby the patient during the procedure. In some embodiments, some or all oflocal microprocessor system 120 and/or its function described above islocated in a bed-side device located near the patient during theprocedure. In some embodiments, some or all of local microprocessorsystem 120 and/or its function described above is located in a cellphone located near the patient during the procedure.

When the USN and UPID information 129 from transmission circuit 125 isreceived by server 130, the PPID information is correlated to theparticular patient to locate and retrieve patient information, historyand treatment parameters from PAT DB 132, which together with USN andUPID information 129 are decrypted by decrypt function 136 and thedevice USN is sent to device and billing database 133.

In some embodiments, device and billing database 133 tracks each deviceserial number and the associated data regarding the particularchip-electrode array 110, such that system 101 can warn if theparticular chip-electrode array 110 has been recalled, is out-of-date(expired due to age), has previously been used (such that re-use of thesingle-use device is contraindicated), is inappropriate for theparticular patient or therapy procedure being requested by the medicalprofessional, or other such problems.

In addition, in some embodiments, device and billing database 133 isused to generate a bill to the patient or their insurance carrier forthe use of that device, wherein the bill can thereby reflect the cost ofthe device as well as the cost of the procedure and other deliverables.The patient information 137 and the device information 139 (e.g., whichincludes, in some embodiments, the number and configuration ofelectrodes 116, the circuitry and software version, and the like) areused to access the proper therapy parameters 138 from the medicalresults and indication database 134. In some embodiments, those therapyparameters 138 are encrypted (e.g., in some embodiments, using thepublic key information 118 sent from the particular chip-electrode array110) by encryption function 135 and transmitted back to localmicroprocessor system 120, wherein in some embodiments, optionaldecryption function 123 decrypts at least some of the information forvisual and/or audio presentation on display output unit 170 (such asdisplaying patient name, medical history and the like for review by theattending medical professional supervising the therapy session so that,for example, that medical professional and/or the patient can verify thecorrect therapy is being applied to the correct patient).

In some embodiments, optional decryption function 123 supplies some orall of the private key information and/or control information 124 neededby circuit 111 to decrypt the control parameters needed for the therapysession. In other embodiments, optional decryption function 123 decryptsonly the patient PII and history information displayed on display 170,and for the control information, leaves that portion of the payload ofdata encrypted for the circuit 111 to decrypt and use to control thetherapy session. In some embodiments, circuit 111 includes a pluralityof transmitter/receivers (that each transmit pulsed or otherwise varyingmicro-current stimulation to an individual one of electrodes 116(wherein a common ground connection is used for the return path of thecurrent) or to a selected pair (or other plurality) of the electrodesthat are chosen/determined in order to apply the current along a chosenpath from selected source electrode(s) (one or more of the plurality ofelectrodes 116) to selected destination electrode(s) (another one ormore of the plurality of electrodes 116). In this way, the selected setpaths and the selected sequence of those paths are chosen to target thedesired shape and size of the volume of tissue to be receiving thetherapy.

Once the integrity of the decrypted version of the returned encrypteddata 124 is validated, the payload of the returned data is used tocontrol the transmit portion of transmit/receive (TX/RX) circuitry 115to deliver micro-stimulation signals that are customized for theparticular patient. In some embodiments, the medical indication databaseprovides the initial values for the amplitude, frequency, duty cycle, DCbalance, and/or other parameters for the transmit signal sent fromtransmit/receive (TX/RX) circuitry 115.

In some embodiments, sensed signals 117 from the electrodes 116 areobtained from the receive portion of transmit/receive (TX/RX) circuitry115 and are processed by process (e.g., feedback-determining) function127 and the pulse-adjust results 118 are used to adjust (e.g., changethe amplitude, frequency, duty cycle, DC balance, and/or otherparameters) the transmit signal sent from transmit/receive (TX/RX)circuitry 115. In some embodiments, the sensed signal is indicative ofthe impedance/resistance seen by a particular electrode or electrodepair. In some embodiments, the sensed signals are from other electrodes(one or more of the plurality of electrodes 116) not involved in thetransmitted pulse and are indicative of nerve signals or otherphysiological processes.

In some embodiments, information reflecting the sensed signals and thecorresponding stimulation (transmitted) signals on electrodes 116 isprocessed and encrypted by function 125 and transmitted to server 130 tobe stored in PAT DB 132 to be associated with this patient and thistherapy session. In some embodiments, reported results information 126reflecting information from the patient as to their feeling about thetherapy session and the results obtained from the therapy is processedand encrypted by function 125 and transmitted to server 130 to be storedin PAT DB 132 to be associated with this patient and this therapysession.

In some embodiments, results information and therapy session informationfrom a large plurality of patients is processed and aggregated bysoftware in server 130 or operating on data supplied by server 130 tomodify the medical indications in database 138 such that over time thetherapy for each patient or each type of patient provide improvedparameters for future therapy sessions.

FIG. 1B is a block diagram of a system 102 for delivering stimulationsignals to at least some of a plurality 116 of electrodes connected tothe skin of a patient and for optionally sensing signals from at leastsome of the plurality 116 of electrodes, according to some embodimentsof the present invention. In some embodiments, much of the functionalityof circuit 111 of system 101 has been moved into a local microprocessorsystem 150, leaving only the electrodes 116 and their conductor traceson a flexible substrate of one-use disposable electrode array 140. Insome embodiments, a unique serial number (USN) is printed on one-usedisposable electrode array 140 or its wrapper, which in someembodiments, is machine readable in the form of a bar code orquick-response (QR)-type symbol 145 or the like. In some embodiments,symbol 145 includes the USN as well as a website identifier that is usedto retrieve a public-key encryption key from an internet site. In someembodiments, the data and software in decryptor/pulse-enable-and-controlmodule 112 functionality that is on chip-electrode array 110 is replacedby data and software in decryptor/pulse-enable-and-control module 152 inlocal microprocessor system 150. In some embodiments,encryptor-encapsulator-transmission circuit 155 includes thefunctionality of encryptor-encapsulator-transmission circuit 125 inaddition to an imager used to capture the image of QR symbol 145 (e.g.,in some embodiments, the camera in a cell phone is used to obtain thedata from symbol 145, and the cell phone provides the functionality, orat least part of the functionality of reference numbers 155, 123, 124,127 and 152). In some embodiments, some of the functionality of localmicroprocessor system 150 (such as decryptor/pulse-enable-and-controlmodule 152, TX/RX 155, and/or display 170) is located on a head-mountedgoggle-type device 201 (such as shown in the diagram in FIG. 1C and FIG.2), and communicates wirelessly to a cell phone that implements theremainder of functions of local microprocessor system 150. The remainderof the functions shown in FIG. 1B are as shown by like reference numbersin FIG. 1A.

FIG. 1C is a diagram of system 103, according to some embodiments of thepresent invention. In some embodiments, system 103 includes thegoggle-type device 201, which, in some embodiments, is configured to beplaced on the head and connected to the electrodes of one-use disposablechip-electrode array 210 (e.g., an array such as array 110 or array 140)that is placed over both upper and lower eyelids, or on another bodypart, along with some of its componentry (e.g., chip 111). In someembodiments, array 210 includes unique serial number information 118that is embedded in one or more integrated circuit chips 111; in otherembodiments, array 210 and/or its wrapper is machine readable in theform of a bar code/UPC code such as quick-response (QR)-type symbol 145or the like. In some embodiments, system 103 further includes headsetframe 211, contact points 212 between the electrode(s) and the headsetframe 211, and electrode skin-contact points 213, numbered from as fewas two (2) per electrode to as many as ten (10) or more (in someembodiments, as shown in FIG. 1C, there are six skin-contact points213). In some embodiments, system 103 further includes side temple piece214 that goes around the side of the head, optional extended lens cover“arm” 215, which, in some embodiments, is used to adjust the contactpressure over the electrodes of the various contact points 213 aroundthe eye socket, and grounding electrode(s) 216 that, in someembodiments, provides a ground connection between headset frame 211 andthe patient's body. Section line 1D-1D of FIG. 1C shows the location ofthe cross-section of FIG. 1D. In some embodiments, not shown in FIG. 1C,system 103 includes a lens cover arm 215, an array 210, and a contactpoint 212 on both sides of headset frame 211.

FIG. 1D is a cross-section diagram (along section line 1D-1D of FIG. 1C)of an electrode-and-gel system 104, according to some embodiments of thepresent invention. In some embodiments, electrode-and-gel system 104includes one-use disposable electrode array 140 having a skin-facingadhesive 161 on flexible and/or elastic substrate 119, wherein theadhesive 161 and electrically conductive gel 163 are covered by aremovable cover 162. In some embodiments, each of the plurality ofconductive electrodes 116 is formed (e.g., by printing, plating and/oretching) on a pocket 165 formed in substrate 119, wherein each pocket165 contains a selected amount of electrically conductive gel 163 heldin place by adhesive 161 and cover 162, until the cover 162 is removedso that one-use disposable electrode array 140 can be applied to theskin of the patient with each portion of gel 163 and its electrode beingelectrically isolated from the other electrodes and their gel. In someembodiments, each electrode 116 is connected to a corresponding one of aplurality of electrical connectors 164 to send and receive signals toand from local microprocessor system 150 (see FIG. 1B).

FIG. 1E is a cross-section diagram of an electrode-and-gel system 105,according to some embodiments of the present invention. In someembodiments, electrode-and-gel system 105 includes one-use disposablechip-electrode array 110 having a skin-facing adhesive 161 on flexibleand/or elastic substrate 119, wherein the adhesive 161 and electricallyconductive gel 163 are covered by a removable cover 162. In someembodiments, each of the plurality of conductive electrodes 116 isformed (e.g., by printing, plating and/or etching) on a pocket 165formed in substrate 119, wherein each pocket 165 contains a selectedamount of electrically conductive gel 163 held in place by adhesive 161and cover 162, until the cover 162 is removed so that one-use disposablechip-electrode array 110 can be applied to the skin of the patient witheach portion of gel 163 and its electrode being electrically isolatedfrom the other electrodes and their gel. In some embodiments, eachelectrode 116 is connected to a corresponding TX/RX 115 of chip 111, andchip 111 communicates information signals 117, 118, 119 and 124 via aplurality of electrical connectors 165 or, in other embodiments,wirelessly by Bluetooth® or WiFi, to local microprocessor system 120(see FIG. 1A).

FIG. 2 is a diagram of goggle-type device 201, according to someembodiments of the present invention. In some embodiments, device 201includes a visual screen 220, incorporated into headset frame 211,indicating a display of the various elements of information visible onscreen at any one time. In some embodiments, device 201 further includesa display-screen frame 221 that includes, for example, two (2) to ten(10) lights 222 on the display screen frame 221 (upper plus lower). Insome embodiments, lights 222 includes light(s) 223 that indicate whichelectrode contact point 213 is currently in session, light(s) 224 thatindicate the level of stimulation, and light(s) 225 that indicate thestimulation time that has elapsed. In some embodiments, lights 222 arealso configured to provide a confirmation or indication that the contactpoints of the electrode are functioning properly and delivering theappropriate level of current chosen to stimulate the eye.

FIG. 3 is a diagram of a goggle-type device 301, according to someembodiments of the present invention. In some embodiments, device 301includes lights on the headset frame (e.g., headset frame 211) to helpthe clinician know the status of treatment. In some embodiments, light322 indicates if there is stimulation impedance, and if the stimulationlevel chosen is being properly delivered; in addition, some embodimentsinclude ON/OFF lights. In some embodiments, the OFF light 325 activatesto indicate that the treatment session has finished. In someembodiments, the ON light 326 illuminates when the treatment session isin process. There may also be individual treatment “session” lights (oneper each electrode stimulation point; e.g., light(s) 223). In someembodiments, the session lights illuminate according to the specifictreatment point being stimulated at that particular moment of thetherapy, enabling the clinician to know exactly where in the treatmentprocess the patient was.

FIG. 4A is a diagram of a goggle-type device 401, according to someembodiments of the present invention. In some embodiments, device 401includes a light filament 422 that is used to provide indicating lightto the patient. In some embodiments, light filament 422 is located onthe interior side of the headset frame (e.g., headset frame 211) suchthat light is projected toward the patient from light filament 422. Asingle or a double filament line may be used for filament 422. In someembodiments, device 401 further includes a vibration filament 430 thatis embedded in the headset frame (e.g., headset frame 211).

FIG. 4B is a diagram of a system 402, according to some embodiments ofthe present invention. In some embodiments, the present invention usesone, two or more electrode strips 440 such as one-use disposablechip-electrode array 110 (as described above for FIG. 1A) or one-usedisposable electrode array 140 (as described above for FIG. 1B) that areelectrically connected to headset 410. In some embodiments, headset 410is worn by the patient during the therapy session, and includes thefunctionality as described above for local microprocessor system 120 (asdescribed above for FIG. 1A) and/or local microprocessor system 150 (asdescribed above for FIG. 1B). In addition, in some embodiments, headset410 includes one or more LEDs 411 that provide flashes or other lightsignals (for the patient to perceive even when their eyes are closed,and/or the medical professional who is administering the micro-currentelectrical stimulation therapy) to indicate that the therapy is workingand/or to provide other feedback or information to the patient ormedical professional. Also, in some embodiments, headset 410 includesone or more haptic vibration devices 415 that provide vibration throughthe frame of headset 410 or by direct contact to the patient's skin (forthe patient to perceive even when their eyes are closed, and/or viawireless transmission to a wrist-worn fitness monitor, Apple Watch®,Fitbit® or the like such that the medical professional who isadministering the micro-current electrical stimulation therapy isnotified to look at information displayed on display 170 or othernotification) to indicate that the therapy is working and/or to provideother feedback or information to the patient or medical professional. Insome embodiments, headset 410 includes an on-board microprocessor andbattery 416 to support the functionality for local microprocessor system120 (as described above for FIG. 1A) and/or local microprocessor system150 (as described above for FIG. 1B). In some embodiments, one-usedisposable chip-electrode array 110 (as described above for FIG. 1A) orone-use disposable electrode array 140 (as described above for FIG. 1B)further include one or more LEDs 422 to provide an indication offunctionality (e.g., that the electrode array 110 or 140 is properlyelectrically connected to headset 410) and/or an indication that therapyis underway. In some embodiments, power for electrode array 440 issupplied by a wired connection 114 on a flexible substrate along withthe connector that lead to electrodes 116. In some embodiments,electrode array 110 or 140 has an adhesive layer 161 (see FIG. 1D) tohold the electrode array 110 or 140 to the patient's skin. In someembodiments, electrode array 110 or 140 is first adhered to the patientin the desired location, then the patient puts on headset 410 and theelectrode arrays 110 or 140 are connected to a corresponding jack orother electrical connection.

FIG. 5 is a diagram of a goggle-type device 501, according to someembodiments of the present invention. In some embodiments, device 501includes a connecting wire 541 that runs from the headset frame (e.g.,headset frame 211) to a bio-electric microcurrent controller device 545.In some embodiments, device 501 includes a bio-electric microcurrentcontroller device 550 that is built into the headset frame (e.g.,headset frame 211). In some embodiments, device 501 includes a sensor560 on the headset frame (e.g., headset frame 211) that providesfeedback to the controller device (e.g., controller device 545 and/orcontroller device 550) for stimulation level being delivered, etc.

FIG. 6 is a diagram of a goggle-type device 601, according to someembodiments of the present invention. In some embodiments, device 601includes a WiFi connection 670 that allows device 601 to connect, viaWiFi, to a separate device such as controller device 545, a server, acomputer, or the like, in order to provide remote access to device 601.

The headset apparatus may contain an LED, LCD, or some other type ofscreen, like a small i-Phone touch screen to show the treatmentsequencing, the status of such treatment, and/or to engage or halt suchtreatment. This screen may show graphics, pictures, or even videofootage related to such treatment process, with the purpose of making iteasier for a clinician to readily assess where the patient is within thetreatment cycle, or to enable the clinician to start, change, or stopsuch treatment cycle. The screen can be a touch screen that enables theclinician to modify the treatment parameters, such as stimulation levelor duration under treatment.

The headset connects via WIFI to server or computer, which recognizesthe individual headset via a unique set of algorithmic codes built intothe headset's control unit. Once the server or computer is connected tothe headset and it recognizes the headset's unique algorithmic code, itcan then enable the headset, when initiated by a clinician or physician,to conduct a treatment session. It can also simultaneously bill orcharge the provider for payment of such treatment session. The headsetcan also send the treatment parameters used to the server or computerfor record of how the device was used. The headset is rechargeable forrepeated use, and it connects to a base station. The base station canplug into the wall to maintain the charge to recharge the headset. Theheadset does not plug into the wall directly for safety purposes.

The apparatus may contain a “light” filament or filaments threadedthrough the headset to convey a low level of light through the patient'sclosed eyes, indicating to the patient, that the appliance/strip isfunctioning as intended. This low level of light will penetrate thepatient's closed eyelid and be received by those photoreceptor cellsfunctioning in the back of the retina. It will resemble a dull flash,and may be either a white light or a specially colored light (such asred or green, like a laser light).

The apparatus may also contain a vibrating filament threaded through theheadset, to convey a light level of vibration as the stimulation isbeing applied. Again, this is for the function of conveying to thepatient that the stimulation is being delivered for those instanceswhere the bio-electric microcurrent, itself, may be simply unfelt by thepatient. The benefit of this is that the patient can feel it working,and will then be more willing to sit and complete the full treatmentsession, versus a session where they have no marker to indicate thatanything is happening.

The application of the apparatus will be performed by the attendingphysician or clinician in the clinic. The patient's eye lids will becleaned with sterile solution contained in a wipe or similar material.The clinician, using sterile surgical gloves, will then open the packetcontaining the headset; the headset will then be mounted on thepatient's head by the clinician. The clinician will then connect theheadset (or goggle)—both forms to be used interchangeably in thefollowing descriptions—to the bio-electric microcurrent strips, and theentire headset will be configured to the patient in the followingmanner:

-   -   The headset will be sized to properly fit the patient in terms        of the size of their head.    -   The headset will be connected to the individual bio-electric        microcurrent strip(s), (electrode)(s) whose contact points will        be placed on the patient's closed eyelids, just below the        eyebrows, across the bone of the upper eye orbit cavity, and        also applied under the eye, along the bone of the lower orbit.    -   The treatment electrode(s) contain an embedded chip to regulate        the performance during treatment, including one-time usage,        identification purposes, and purchase confirmation by clinic or        user.    -   The headset is also connected to one or two grounding electrodes        placed at another point on the body to complete the closed        circuit of the individual bio-electric microcurrent strips.    -   The headset would be connected to the bio-electric microcurrent        device (i.e. controller), built into the headset, or connected        via wire when it is a separate device, or connected via WIFI        when it is a separate device, to initiate therapy.

In some embodiments, when the therapy is finished, a beeper will sound.The clinician will then disconnect the headset from the electrodes, andin the case of a separate control device, from the separate controldevice if it is attached via wires generating the bio-electricmicrocurrent. Next, the clinician will gently remove the headset fromthe patient. The headset will be cleaned in accordance with companyinstructions as guided by any government directives, or in the case of adisposable headset, disposed of in accordance with any governmentdirectives. The patient's eye(s) will be re-cleansed with a sterilewipe/pad.

Advantages of the New Technology Microstimulation Headset Frame

-   a. It is an advantage of the present invention to provide a novel    electrode apparatus for providing bio-electric microcurrent    stimulation therapy to a body part to combat chronic pain, injury,    or disease in that body part, or to assess or monitor internal organ    function within the body.-   b. Another advantage of the present invention is to provide a novel    electrode apparatus for treating various diseases, including macular    degeneration and retinitis pigmentosa.-   c. Yet another advantage of the present invention is to provide an    electrode apparatus that delivers bio-electric microcurrent    stimulation therapy via a headset frame attached to electrodes that    are wired to (or connected via WIFI to) the control apparatus and    are positioned on the upper or lower eye lid with an adhesive    material.-   d. Yet another advantage of the headset is that the clinician can    begin treatment and leave the patient during the treatment cycle for    multi-tasking efficiency and reducing clinician labor.-   e. Yet another advantage is that the clinician can be away from the    patient, but periodically check on the patient's progress with the    headset's screen.-   f. Yet another advantage of the headset/goggle device, with the    connected electrodes, is the automation of the treatment process and    its ability to deliver a consistent treatment, thereby minimizing    variability of such treatment that otherwise would be present if it    were delivered manually by a clinician in terms of: time, pressure    of the electrode at the point of stimulation, consistency of    application, contact of the electrode, and consistency of the    stimulation level being delivered as initially selected for    treatment setup.-   g. Yet another advantage is that both eyes are set up simultaneously    for treatment, saving time since there is just one set up. (The    patient may have one eye treated at a time and then the other,    during the treatment cycle, OR the headset could be configured to    simultaneously treat both eyes at once, one electrode point at a    time per each eye until the cycle is completed.)-   h. Yet another advantage of the headset's inner circular frame is    that it will comfortably and easily fit most patients' heads and    make for easy connection of the electrodes around the eye.-   i. This headset contains or will be connected to various numbers of    electrodes or sensors, which are wired and sensed individually by a    controller device, which gives the ability of the apparatus to    monitor the current supplied to the various contact points in the    electrodes, and to adjust the current based upon the degree of    impedance.-   j. The invention will be packaged as sanitary, depending upon the    requirements in a barrier-proof package.-   k. Yet another advantage is this headset apparatus will be connected    to a software program that can administer the treatment therapy, and    can also collect patient information regarding the application of    the treatment applied to the patient, for improved patient outcomes.-   l. Yet another advantage is that the invention contains one or a    number of light filaments in the headset frame, that can signal the    patient that the proper level of therapy is being delivered to the    patient and that they are not experiencing undue impedance.-   m. Yet another advantage is in the field of safety, as the device    cannot be randomly used since it needs to be pre-authorized by the    server or computer, via the unique algorithm, to conduct the    treatment session.-   n. Yet another advantage is that the payment for each treatment is    monitored on an individual basis by the server or computer, with    each session used being specifically enabled by the server/computer,    tracked, and accounted for, so it can be paid for by the clinic.-   o. Yet another advantage is that the clinician can see the status of    the therapy in session and or modify it at any time, with the use of    the headset's touch screen.-   p. Yet another advantage is the headset plugs into a base station    device that recharges the headset, so that the headset can be    recharged and used repeatedly, and so that the headset does not    directly plug into the wall, which is a usage safety guard for the    patient per regulatory codes.-   q. Yet another advantage is that the treatment electrodes contain a    chip, similar to a security chip in a credit card but optionally    with additional functionality such as a controller and current    drivers and receiving preamplifiers and the like, which enables a    one-time use and can be tracked via the headset controller. This    prevents the reuse of electrodes for a safety and hygiene basis, as    well as insures proper accounting for the electrodes from a purchase    and billing standpoint. This chip technology will enable    confirmation of: electrode identity and authenticity, purchase, and    one-time usage.-   r. Accordingly, it is an advantage of the present invention to    incorporate a safety element by individually wiring each electrode    sensor point connected to the treatment device, which provides the    bio-electric stimulation. Such design prevents more than one    electrode point delivering the therapy simultaneously, unless so    specifically programmed, and potentially injuring the patient.-   s. The advantage of this apparatus is that the bio-electric    stimulation is not carried simultaneously over the entire surface of    the treated area, and that an individually targeted area of the eye    can be treated with stimulation therapy, while not stimulating other    areas of the eye or surrounding tissues. Stimulation is delivered at    differing specific individual points in a programmed manner, versus    the current standard of a general stimulation delivery over the    affected area in the many other medical fields where electrode    stimulation is used.-   t. The advantage of highly targeted bio-electric stimulation is that    this ensures that a more concentrated delivery is made to the    targeted area, with a greater chance of deeper inner penetration of    the stimulation, to the back of the retinal tissues, where it can do    the most good to reactivate cellular activity, and avoiding higher    levels of stimulation, which might otherwise be required without    such targeting, which can incidentally cause damage to the more    sensitive tissues.-   u. Another advantage is that specific areas of bio-electric    stimulation can be chosen by the physician, as determined by the    program used in the bio-electric microcurrent device connected to    the headset/apparatus. It has specifically sequenced points within    the electrodes that can deliver timed specific stimulation to    different points along the frame itself, in a pre-set sequence, for    a varied or pre-set time, at an individual point of contact, or at    two or more points of individual contact, with preset stimulation    levels, as opposed to a single Gel Pad which offers blanket    stimulation over the entire surface area of the pad.-   v. Another advantage of this appliance and its treatment methodology    is that it enables the physician to target bio-electric stimulation    to a particular treatment point (as small as 1-2 millimeters, or as    large as 5-10 millimeters), which improves treatment efficacy since    a higher current dose cannot be tolerated by the body at a small    pinpoint of delivery, or be effective if delivered over a larger    surface area, such as by a standard gel pad. Further, this    bio-electric stimulation can be delivered to a specifically designed    and tolerated treatment point within a timed sequence and then on to    another in a pre-set pattern designed to optimize treatment results    for patients.

Elements of Apparatus Design According to Some Embodiments

-   a) Method for Application to upper, and/or lower eye, as well as    other body parts.-   b) Bio-electric Microcurrent Headset Frame.-   c) Headset Frame connects to electrodes, which stimulate the upper    and lower eyelid, or other body part(s) as applied, using an    electrode with a gel coating.

a. Such electrodes contain a chip and this technology serves to identifythe electrode using this chip to the controller as authentic, to allow aone-time use for safety and hygiene purposes, and to ensure paymentregulation.

-   d) Headset frame connects to electrodes which:    -   1. Have between 1-10 (or more) contact points on the top of the        strip for the top closed eye lid or skin covering the upper        orbit.    -   2. Have between 1-10 (or more) contact points on the bottom of        the strip for the bottom closed eye lid or skin covering the        lower orbit.    -   3. Do not stimulate entire eye, only under those specific points        selected within the stimulation program determined by physician        and programmed into device.    -   4. Contact points can be individual or multiple, meaning that        ONE contact point can stimulate at a time per eye, or body part;        OR two to several contact points may stimulate simultaneously,        determined by the program selected on the device. (In addition,        the entirety of the strip(s), and all of the contact points may        also be active with stimulation at any one given point during        the treatment in addition to the individual points stimulated.)    -   5. Contact points may stimulate individually or in multiple        points, in a pre-programmed sequence, with a pattern that is        pre-set in terms of specific stimulation level(s), individual        stimulation point duration time(s), total program run time,        number of times of stimulation per eye point, etc., all of which        is determined by the program in the device, selected by the        attending clinician delivering the stimulation.    -   6. Contact points are capable of receiving varied stimulation        levels as determined by device. (Meaning that the stimulation        level delivered through the various contact points can vary and        be increased or decreased throughout the course of the treatment        program selected.)-   e) This invention makes it is less labor intensive to conduct the    treatment (since the clinician can turn the headset on, start the    programmed treatment, and go off to do another task while the    program runs its course); less time consuming (since the clinician    is freed up during the programs duration to attend to other tasks),    and less fatiguing (since the clinician does not need to stand over    the patient and hold the stimulation probe.)-   f) Safety Element: The headset and its controller (whether built in    or attached via wires) rely on a safety governor built in to the    controller device, so one point cannot deliver more than 350    microamps of current. Sensors: Headset, controller, and strips have    a built-in sensor to monitor stimulation level delivered to improve    treatment performance:    -   1. Sensor also gauges impedance of skin:    -   2. Sensor to give feedback to device to actual stimulation        delivered to skin. (Feedback loop)    -   3. Sensor to automatically adjust bio-electric current level        deliver to patient, to achieve the selected/programmed        stimulation level, regardless of impedance. (Up to 350        microamps, and no more.)-   g) Headset may contain an internal light filament built in to frame    to indicate stimulation delivery to patient. Filament would flash    lightly in conjunction with the delivery of the stimulation. This    feature can be manually turned off for no flash.-   h) Headset may contain an external visible light for the clinician    to monitor treatment. Light will go from constant (when selected    stimulation is appropriately delivered); to flash if stimulation    being delivered has impedance and is under-delivered; or, to rapid    flash if impedance is high and stimulation being delivered is    significantly under-delivered.-   i) Headset may contain a vibration element built into frame,    designed to indicate stimulation delivery.-   j) Headset either has a built-in controller or contains a connection    element to primary controller device, via either wires or via WIFI.    -   1. The controller has a unique algorithm ensuring its        identification and connection to the server or computer.    -   2. Each controller can be identified as to location and modified        by the company as to its operational capabilities, permitting        the company to upgrade the controller software and operating        system at any time.    -   3. The controller requires the connection to the server or        computer for activation of the therapy to ensure control over        the therapy sessions being delivered and to ensure proper        payment for such sessions.-   k) Headset has a built-in touch screen (in some embodiments,    smaller, but similar to an Apple iPhone®). This touch screen enables    the clinician to start the program; to stop the program; and to    adjust any of the treatment variables. It also features a display    with a read-out of the treatment status in progress.-   l) Headset may have two moveable or “flip-oriented” lens covers,    (one around each eye), that are lens-less, but designed to come in    moderately tight contact, (¼# {one-quarter pound} to 15# {fifteen    pounds} pressure per square inch), with the closed upper and lower    eye lid, to ensure proper contact with the electrode. This could be    done via a spring mounted to the lens cover arm, as it is flipped    down to cover the electrode strip(s), or some other form of applying    pressure to the lens cover arm.-   m) The headset design can be adjusted to accommodate different sized    anatomical head configurations.-   n) Headset may contain a sensor for feedback to device to register    stimulation level being delivered.-   o) Headset may contain a timing sensor (buzzer/chime) to notify when    session is completed.-   p) Headset may contain an LED or LCD type of screen, in some    embodiments, similar to a small iPod® screen, showing the status of    the treatment session, including which eye is being stimulated,    which eye point is being stimulated, where in the cycle of    stimulation the treatment session is, and when the session has    ended. This visual screen will also show product name, program time    elapsed, and stimulation level being delivered to patient.

In some embodiments, the present invention provides an apparatus forapplying bio-electric microcurrent stimulation therapy to the humanbody, via a disposable chip-electrode array that connects to amicro-stimulation current generating device, for application of themicrocurrent stimulation therapy. In some embodiments, the apparatusincludes a headset device for mounting to the patient's head; and one ormore electrode strips such as a one-use disposable chip-electrode arrayhaving a unique serial number or crypto code and other functionalitythat is used by the system to look up and deliver customized therapy toa particular patient having their own particular symptoms and medicalhistory, which deliver the stimulation to the patient's skin.

In some embodiments, the present invention provides a method forapplying bio-electric microcurrent stimulation therapy to the human bodyof a particular patient, via a disposable chip-electrode array stripssuch as a one-use disposable chip-electrode array having a unique serialnumber or crypto code that connects to a micro-stimulation currentgenerating headset, for application of the microcurrent stimulationtherapy. This method includes mounting the headset to the patient'shead; applying one or more electrode strips to the patient's skin;connecting the one or more electrode strips to the headset;communicating the unique serial number or crypto code to a computerserver; using the unique serial number or crypto code in the computerserver to look up and return a customized therapy regimen specificationto the headset for the a particular patient having their own particularsymptoms and medical history; and using the customized therapy regimenspecification, deliver the microcurrent stimulation to the patient'sskin.

In some embodiments, the present invention provides a non-transitorycomputer-readable medium having instructions stored thereon for causinga suitably programmed information processor to execute a method forapplying bio-electric microcurrent stimulation therapy to the human bodyof a particular patient, via a disposable chip-electrode array stripssuch as a one-use disposable chip-electrode array having a unique serialnumber or crypto code that connects to a micro-stimulation currentgenerating headset, for application of the microcurrent stimulationtherapy. This method includes mounting the headset to the patient'shead; applying one or more electrode strips to the patient's skin;connecting the one or more electrode strips to the headset. Theinstructions cause the suitably programmed information processor toexecute a method that includes: communicating the unique serial numberor crypto code to a computer server; using the unique serial number orcrypto code in the computer server to look up and return a customizedtherapy regimen specification to the headset for the a particularpatient having their own particular symptoms and medical history; andusing the customized therapy regimen specification, deliver themicrocurrent stimulation to the patient's skin.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Although numerous characteristics andadvantages of various embodiments as described herein have been setforth in the foregoing description, together with details of thestructure and function of various embodiments, many other embodimentsand changes to details will be apparent to those of skill in the artupon reviewing the above description. The scope of the invention shouldbe, therefore, determined with reference to the appended claims, alongwith the full scope of equivalents to which such claims are entitled. Inthe appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein,” respectively. Moreover, the terms “first,” “second,” and“third,” etc., are used merely as labels, and are not intended to imposenumerical requirements on their objects.

1. (canceled)
 2. The system of claim 55, wherein the parameters arefurther based on particular symptoms and medical history associated withthe patient.
 3. A system for applying bio-electric microcurrentstimulation therapy to a patient, the system comprising: a head-mounteddevice configured to be mounted to the patient's head; achip-electrode-array circuit operatively coupled to the head-mounteddevice, wherein the chip-electrode-array circuit includes at least oneintegrated-circuit chip and at least one electrode-array stripconfigured to deliver the bio-electric microcurrent stimulation therapyto the patient, wherein the chip-electrode-array circuit includes aunique identification number; and a computer server operatively coupledto the chip-electrode-array circuit, wherein the chip-electrode-arraycircuit is configured to communicate with the computer server in orderto have the computer server look up parameters based at least in part onthe unique identification number and communicate the looked-upparameters to the chip-electrode-array circuit for the bio-electricmicrocurrent stimulation therapy, wherein the unique identificationnumber is a serial number stored in the at least one integrated-circuitchip and communicated from the at least one integrated-circuit chip tothe computer server.
 4. A system for applying bio-electric microcurrentstimulation therapy to a patient, the system comprising: a head-mounteddevice configured to be mounted to the patient's head; achip-electrode-array circuit operatively coupled to the head-mounteddevice, wherein the chip-electrode-array circuit includes at least oneintegrated-circuit chip and at least one electrode-array stripconfigured to deliver the bio-electric microcurrent stimulation therapyto the patient, wherein the chip-electrode-array circuit includes aunique identification number; and a computer server operatively coupledto the chip-electrode-array circuit, wherein the chip-electrode-arraycircuit is configured to communicate with the computer server in orderto have the computer server look up parameters based at least in part onthe unique identification number and communicate the looked-upparameters to the chip-electrode-array circuit for the bio-electricmicrocurrent stimulation therapy, wherein the unique identificationnumber is a serial number printed on the at least one electrode-arraystrip and read by a camera to obtain image data that is communicated tothe computer server.
 5. The system of claim 55, wherein thechip-electrode-array circuit is a one-use disposablechip-electrode-array circuit.
 6. A system for applying bio-electricmicrocurrent stimulation therapy to a patient, the system comprising: ahead-mounted device configured to be mounted to the patient's head; achip-electrode-array circuit operatively coupled to the head-mounteddevice, wherein the chip-electrode-array circuit includes at least oneintegrated-circuit chip and at least one electrode-array stripconfigured to deliver the bio-electric microcurrent stimulation therapyto the patient, wherein the chip-electrode-array circuit includes aunique identification number; and a computer server operatively coupledto the chip-electrode-array circuit, wherein the chip-electrode-arraycircuit is configured to communicate with the computer server in orderto have the computer server look up parameters based at least in part onthe unique identification number and communicate the looked-upparameters to the chip-electrode-array circuit for the bio-electricmicrocurrent stimulation therapy, wherein the unique identificationnumber includes public-key encryption information that is used by thecomputer server to encrypt data sent to the chip-electrode-arraycircuit.
 7. The system of claim 55, wherein the computer server includesa medical-results-and-indication database, and wherein results of thebio-electric microcurrent stimulation therapy are transmitted to themedical-results-and-indication database to be analyzed in order toimprove future therapy sessions.
 8. The system of claim 55, wherein thechip-electrode-array circuit includes a microprocessor integrated withthe chip-electrode-array circuit.
 9. The system of claim 55, furthercomprising: a local microprocessor system operatively coupled to thechip-electrode-array circuit.
 10. The system of claim 55, furthercomprising: a local microprocessor system operatively coupled to thechip-electrode-array circuit, wherein the local microprocessor systemincludes a first portion located on the head-mounted device and a secondportion located remotely from the head-mounted device.
 11. (canceled)12. The method of claim 13, wherein the received parameters are furtherbased on particular symptoms and medical history associated with thepatient.
 13. A method for applying bio-electric microcurrent stimulationtherapy to a patient via a chip-electrode-array circuit that includes atleast one integrated-circuit chip, at least one electrode-array strip,and a unique identification number, the method comprising: providing ahead-mounted device; connecting the at least one electrode-array stripto the head-mounted device; mounting the head-mounted device to thepatient's head such that the head-mounted device applies the at leastone electrode-array strip to the patient's skin; transmittinginformation from the chip-electrode-array circuit to a computer server,wherein the transmitted information includes the unique identificationnumber; receiving into the chip-electrode-array circuit, from thecomputer server, parameters for the bio-electric microcurrentstimulation therapy, wherein the received parameters are based at leastin part on the unique identification number; and delivering, via the atleast one electrode-array strip, the bio-electric microcurrentstimulation therapy to the patient based on the received parameters,wherein the unique identification number is a serial number stored inthe at least one integrated-circuit chip, and wherein the transmittingof the information includes communicating the serial number from the atleast one integrated-circuit chip to the computer server.
 14. A methodfor applying bio-electric microcurrent stimulation therapy to a patientvia a chip-electrode-array circuit that includes at least oneintegrated-circuit chip, at least one electrode-array strip, and aunique identification number, the method comprising: providing ahead-mounted device; connecting the at least one electrode-array stripto the head-mounted device; mounting the head-mounted device to thepatient's head such that the head-mounted device applies the at leastone electrode-array strip to the patient's skin; transmittinginformation from the chip-electrode-array circuit to a computer server,wherein the transmitted information includes the unique identificationnumber; receiving into the chip-electrode-array circuit, from thecomputer server, parameters for the bio-electric microcurrentstimulation therapy, wherein the received parameters are based at leastin part on the unique identification number; and delivering, via the atleast one electrode-array strip, the bio-electric microcurrentstimulation therapy to the patient based on the received parameters,wherein the unique identification number is a serial number printed onthe at least one electrode-array strip, and wherein the transmitting ofthe information includes reading, using a camera, the printed serialnumber to obtain image data and communicating the obtained image data tothe computer server.
 15. The method of claim 13, wherein thechip-electrode-array circuit is a one-use disposablechip-electrode-array circuit.
 16. A method for applying bio-electricmicrocurrent stimulation therapy to a patient via a chip-electrode-arraycircuit that includes at least one integrated-circuit chip, at least oneelectrode-array strip, and a unique identification number, the methodcomprising: providing a head-mounted device; connecting the at least oneelectrode-array strip to the head-mounted device; mounting thehead-mounted device to the patient's head such that the head-mounteddevice applies the at least one electrode-array strip to the patient'sskin; transmitting information from the chip-electrode-array circuit toa computer server, wherein the transmitted information includes theunique identification number; receiving into the chip-electrode-arraycircuit, from the computer server, parameters for the bio-electricmicrocurrent stimulation therapy, wherein the received parameters arebased at least in part on the unique identification number; anddelivering, via the at least one electrode-array strip, the bio-electricmicrocurrent stimulation therapy to the patient based on the receivedparameters, wherein the unique identification number includes public-keyencryption information, the method further comprising encrypting datasent to the chip-electrode-array circuit from the computer server usingthe public-key encryption information.
 17. The method of claim 13,further comprising transmitting results of the bio-electric microcurrentstimulation therapy to a database located on the computer server; andanalyzing the results in order to improve future therapy sessions. 18.The method of claim 13, further comprising integrating a microprocessorwith the chip-electrode-array circuit.
 19. The method of claim 13,further comprising: providing a local microprocessor system; andcoupling the local microprocessor system to the chip-electrode-arraycircuit.
 20. The method of claim 13, further comprising: providing alocal microprocessor system, wherein the local microprocessor systemincludes a first portion and a second portion; and coupling the firstportion of the local microprocessor system to the head-mounted device,wherein the second portion of the local microprocessor system is locatedremotely from the head-mounted device.
 21. (canceled)
 22. Thenon-transitory computer-readable medium of claim 25, further comprisinginstructions such that the received parameters are further based onparticular symptoms and medical history associated with the patient. 23.A non-transitory computer-readable medium having instructions storedthereon for causing a suitably programmed information processor toexecute a method for applying bio-electric microcurrent stimulationtherapy to a patient via a chip-electrode-array circuit that includes atleast one integrated-circuit chip, at least one electrode-array strip,and a unique identification number, wherein the chip-electrode-arraycircuit is coupled to a head-mounted device, the method comprising:transmitting information from the chip-electrode-array circuit to acomputer server, wherein the transmitted information includes the uniqueidentification number; receiving into the chip-electrode-array circuit,from the computer server, parameters for the bio-electric microcurrentstimulation therapy, wherein the received parameters are based at leastin part on the unique identification number; and delivering, via the atleast one electrode-array strip, the bio-electric microcurrentstimulation therapy to the patient based on the received parameters,wherein the unique identification number is a serial number stored inthe at least one integrated-circuit chip, and wherein the transmittingof the information includes communicating the serial number from the atleast one integrated-circuit chip to the computer server.
 24. Anon-transitory computer-readable medium having instructions storedthereon for causing a suitably programmed information processor toexecute a method for applying bio-electric microcurrent stimulationtherapy to a patient via a chip-electrode-array circuit that includes atleast one integrated-circuit chip, at least one electrode-array strip,and a unique identification number, wherein the chip-electrode-arraycircuit is coupled to a head-mounted device, the method comprising:transmitting information from the chip-electrode-array circuit to acomputer server, wherein the transmitted information includes the uniqueidentification number; receiving into the chip-electrode-array circuit,from the computer server, parameters for the bio-electric microcurrentstimulation therapy, wherein the received parameters are based at leastin part on the unique identification number; and delivering, via the atleast one electrode-array strip, the bio-electric microcurrentstimulation therapy to the patient based on the received parameters,wherein the unique identification number is a serial number printed onthe at least one electrode-array strip, and wherein the transmitting ofthe information includes reading, using a camera, the printed serialnumber to obtain image data and communicating the obtained image data tothe computer server.
 25. A non-transitory computer-readable mediumhaving instructions stored thereon for causing a suitably programmedinformation processor to execute a method for applying bio-electricmicrocurrent stimulation therapy to a patient via a chip-electrode-arraycircuit that includes at least one integrated-circuit chip, at least oneelectrode-array strip, and a unique identification number, wherein thechip-electrode-array circuit is coupled to a head-mounted device, themethod comprising: transmitting information from thechip-electrode-array circuit to a computer server, wherein thetransmitted information includes the unique identification number;receiving into the chip-electrode-array circuit, from the computerserver, parameters for the bio-electric microcurrent stimulationtherapy, wherein the received parameters are based at least in part onthe unique identification number; and delivering, via the at least oneelectrode-array strip, the bio-electric microcurrent stimulation therapyto the patient based on the received parameters, wherein the uniqueidentification number includes public-key encryption information, thenon-transitory computer-readable medium further comprising instructionssuch that the method further comprises: encrypting data sent to thechip-electrode-array circuit from the computer server using thepublic-key encryption information.
 26. The non-transitorycomputer-readable medium of claim 25, further comprising instructionssuch that the method further comprises: transmitting results of thebio-electric microcurrent stimulation therapy to a database located onthe computer server; and analyzing the results in order to improvefuture therapy sessions.
 27. (canceled)
 28. The apparatus of claim 31,further comprising at least a first ground electrode coupled to thehead-mounted device and configured to be placed at a ground location onthe patient.
 29. The apparatus of claim 31, wherein the head-mounteddevice includes a display configured to present information related tothe bio-electric microcurrent stimulation therapy.
 30. The apparatus ofclaim 31, wherein the head-mounted device includes a plurality oflight-emitting-diodes (LEDs) configured to provide light signals thatprovide information related to the bio-electric microcurrent stimulationtherapy.
 31. An apparatus for applying bio-electric microcurrentstimulation therapy to a patient, the apparatus comprising: ahead-mounted device configured to mount to a head of the patient,wherein the head-mounted device includes at least a first hapticvibration device configured to provide vibration that providesinformation related to the bio-electric microcurrent stimulationtherapy; a plurality of electrodes coupled to the head-mounted devicesuch that the plurality of electrodes contact the patient at a pluralityof contact points when the head-mounted device is worn by the patient,wherein the plurality of electrodes is configured to deliver thebio-electric microcurrent stimulation therapy to the patient via theplurality of contact points; a controller operatively coupled to theplurality of electrodes and configured to control electrical currentthat passes through the plurality of electrodes during delivery of thebio-electric microcurrent stimulation therapy; and a pressure deviceconfigured to control a contact pressure of the plurality of electrodesat the plurality of contact points.
 32. The apparatus of claim 31,wherein the plurality of electrodes is part of at least a firstdisposable chip-electrode-array circuit.
 33. The apparatus of claim 31,wherein the plurality of electrodes is part of at least a firstdisposable chip-electrode-array circuit on a flexible substrate, andwherein the flexible substrate further includes an adhesive layer andelectrically conductive gel.
 34. The apparatus of claim 31, wherein thecontroller is built into the head-mounted device.
 35. The apparatus ofclaim 31, wherein the controller is located separately from thehead-mounted device and is wirelessly coupled to the head-mounteddevice.
 36. The apparatus of claim 31, wherein the plurality ofelectrodes is part of at least a first disposable chip-electrode-arraycircuit that includes a unique serial number (USN) that identifies theat least first disposable chip-electrode-array circuit and allowsencrypted communications between the controller and a remote server thatcontains medical and therapy information associated with the patient.37. The apparatus of claim 31, further comprising sensors operativelycoupled to the controller and configured to provide feedback related tothe bio-electric microcurrent stimulation therapy. 38-41. (canceled) 42.The method of claim 49, further comprising: providing a first groundelectrode; coupling the first ground electrode to the head-mounteddevice; and placing the first ground electrode at a ground location onthe patient.
 43. The method of claim 49, further comprising: displayinginformation related to the bio-electric microcurrent stimulationtherapy.
 44. The method of claim 49, wherein the head-mounted deviceincludes a plurality of light-emitting-diodes (LEDs), the method furthercomprising: generating light signals using the plurality of LEDs inorder to provide information related to the bio-electric microcurrentstimulation therapy.
 45. The method of claim 49, wherein thehead-mounted device includes at least a first haptic vibration device,the method further comprising: generating vibration signals using the atleast first haptic vibration device in order to provide informationrelated to the bio-electric microcurrent stimulation therapy.
 46. Themethod of claim 49, further comprising: providing a flexible substratethat includes an adhesive layer and electrically conductive gel; andmounting the at least a first disposable chip-electrode-array circuit onthe flexible substrate.
 47. The method of claim 49, wherein thecontrolling of the electrical current occurs within the head-mounteddevice.
 48. The method of claim 49, wherein the controlling of theelectrical current occurs remote from the head-mounted device.
 49. Amethod for applying bio-electric microcurrent stimulation therapy to apatient via a disposable chip-electrode-array circuit that connects to amicro-stimulation current generating head-mounted device, the methodcomprising: mounting the head-mounted device to the patient's head;applying one or more electrode strips of the disposablechip-electrode-array circuit to a plurality of contact points on thepatient's skin; connecting the one or more electrode strips to thehead-mounted device; controlling electrical current that passes throughthe one or more electrode strips during delivery of the bio-electricmicrocurrent stimulation therapy; and controlling a contact pressure ofthe one or more electrode strips at the plurality of contact points,wherein the disposable chip-electrode-array circuit includes a uniqueserial number (USN) that identifies the disposable chip-electrode-arraycircuit for a remote server that contains medical and therapyinformation associated with the patient, wherein the controlling of theelectrical current includes transmitting and receiving encryptedcommunications between the chip-electrode-array circuit and the remoteserver.
 50. The method of claim 49, further comprising: providing one ormore sensors operatively coupled to the head-mounted device, wherein thecontrolling of the electrical current includes receiving feedback fromthe one or more sensors during the applying of the bio-electricmicrocurrent stimulation therapy. 51-53. (canceled)
 54. The system ofclaim 6, wherein the unique identification number is stored in the atleast one integrated-circuit chip and communicated from the at least oneintegrated-circuit chip to the computer server.
 55. A system forapplying bio-electric microcurrent stimulation therapy to a patient, thesystem comprising: a head-mounted device configured to be mounted to thepatient's head; a chip-electrode-array circuit operatively coupled tothe head-mounted device, wherein the chip-electrode-array circuitincludes at least one integrated-circuit chip and at least oneelectrode-array strip configured to deliver the bio-electricmicrocurrent stimulation therapy to the patient, wherein thechip-electrode-array circuit includes a unique identification number;and a computer server operatively coupled to the chip-electrode-arraycircuit, wherein the chip-electrode-array circuit is configured tocommunicate with the computer server in order to have the computerserver look up parameters based at least in part on the uniqueidentification number and communicate the looked-up parameters to thechip-electrode-array circuit for the bio-electric microcurrentstimulation therapy, wherein the unique identification number is printedon the at least one electrode-array strip and read by a camera to obtainimage data that is communicated to the computer server.
 56. A system forapplying bio-electric microcurrent stimulation therapy to a patient, thesystem comprising: a head-mounted device configured to be mounted to thepatient's head; a chip-electrode-array circuit operatively coupled tothe head-mounted device, wherein the chip-electrode-array circuitincludes at least one integrated-circuit chip and at least oneelectrode-array strip configured to deliver the bio-electricmicrocurrent stimulation therapy to the patient, wherein thechip-electrode-array circuit includes a unique identification number;and a computer server operatively coupled to the chip-electrode-arraycircuit, wherein the chip-electrode-array circuit is configured tocommunicate with the computer server in order to have the computerserver look up parameters based at least in part on the uniqueidentification number and communicate the looked-up parameters to thechip-electrode-array circuit for the bio-electric microcurrentstimulation therapy, wherein the at least one electrode-array stripincludes a plurality of electrodes configured to contact the patient ata plurality of electrode-contact points, the system further comprising aplurality of light emitters, wherein the plurality of light emitters isconfigured to indicate which of the plurality of electrode-contactpoints is activated during delivery of the bio-electric microcurrentstimulation therapy.
 57. The system of claim 3, wherein the uniqueidentification number includes public-key encryption information. 58.The system of claim 55, wherein the unique identification number ismachine readable in the form of a quick-response (QR) symbol.
 59. Thesystem of claim 55, wherein the unique identification number is machinereadable in the form of a bar code.
 60. The system of claim 55, whereinthe at least one integrated-circuit chip is configured to authenticateitself.
 61. The system of claim 3, wherein the at least oneintegrated-circuit chip of the chip-electrode-array circuit is used toconfirm electrode identity and authenticity of the at least oneelectrode-array strip.